Safety, Tolerability and PK of TPOXX in Adults Weighing More Than 120 KG

Inclusion Criteria

• Subject is male or female between 18 and 50 years of age, inclusive.
• Subject has a body weight >120 kg at screening, at check-in on Day -1, and prior to dosing on Day 1.
• Women of childbearing potential, have a negative β human chorionic gonadotropin pregnancy test (serum) at the screening visit and a confirmatory negative serum pregnancy test on Day -1 before receipt of study drug, and meet 1 of the following criteria:
• The subject or their partner has undergone surgical sterilization
• The subject is postmenopausal, defined as 12 consecutive months with no menses without an alternative medical cause and has a documented plasma follicle-stimulating hormone level >40 IU/mL
• The subject agrees to be abstinent (ie, heterosexually inactive or women in a religious order)
• The subject agrees to consistently use 1 of the following methods of contraception from the beginning of screening (which they had been consistently using for at least 30 days before the first dose of study drug) through 30 days after the last dose of study drug:

i. Condoms, male or female, with a spermicide NOTE: For male subjects, condoms must be used for 90 days after the last dose of study drug.

ii. Diaphragm or cervical cap with spermicide

iii. Intrauterine device with spermicide

iv. Oral contraceptives or other hormonal methods NOTE: Subject must agree to use an additional nonhormonal method of contraception in conjunction with oral contraceptives.

v. Male sexual partner who had undergone a vasectomy at least 3 months before screening

• Male subjects must agree to not donate sperm from the first dose of study drug through 90 days after the last dose of study drug.
• Subject is considered by the investigator to be in good general health as determined by medical history (no hospitalizations for chronic medical conditions in the previous 2 years), clinical laboratory results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at screening.
• Subject agrees to comply with all protocol requirements.
• Subject is able to provide written informed consent.
• Subject agrees to comply with the dietary requirements.
• Subject does not intend to lose

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from the study:

• Subject is a female who is pregnant or breastfeeding or planning to become pregnant within 3 months after the last dose of study drug.
• Subject has a history of any clinically significant conditions including:
• Asthma treated with oral systemic steroids within the past 6 months
• Diabetes mellitus (type 1 or 2), with the exception of gestational diabetes
• Thyroidectomy or thyroid disease that required medication within the past 12 months
• Serious angioedema episodes within the previous 3 years or requiring medication in the previous 2 years
• Head trauma resulting in a diagnosis of traumatic brain injury other than concussion
• Frequent episodes of headache.
• Subject has received treatment in another clinical study of an investigational drug (or medical device) within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug.
• Subject has been previously enrolled in any clinical study involving TPOXX (tecovirimat).
• Subject has a history of relevant drug and/or food allergies (ie, allergy to tecovirimat or excipients, or any significant food allergy that could preclude a standard diet in the study site).
• Subject has any condition possibly affecting drug absorption (eg, previous surgery on the gastrointestinal tract, including removal of parts of the stomach, bowel, liver, gallbladder, or pancreas, with the exception of appendectomy).
• Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of the first dose of study drug), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiat